Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442442
Status:
UNKNOWN
Last Update Posted:
2007-10-31
First Post:
2007-03-01
Brief Title:
Clinical Evaluation of Mosquito Coils to Control Malaria in China
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Clinical Evaluation of Mosquito Coils to Control Malaria in China
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although mosquito coils are widely used there is no robust evidence that their use can provide clinical reduction in malaria This study will randomise 4 groups of 400 houses each with 5 people in rural China and monitor cases of malaria in each group each month for 6 months The treatment groups will include Coils Treated bed nets Coils plus treated bed nets or no treatment control All cases detected will be given prompt appropriate treatment
Detailed Description:
Mosquito coils are extremely widely used by households across the world and reportedly make up the largest single family expenditure on any health-related items in many developing Countries Despite their widespread use there has been no robust clinical evaluation to determine whether they can provide protection from malaria This study is designed to determine if using coils and or LLIN each evening can reduce malaria at the household level
The study will be a single-blind randomised clinical evaluation clustered at the household level There will be 4 treatment arms Coils Insecticide treated nets Coils ITN No treatment Each arm will include 400 households each with 5 people household total of 8000 people A maximum of 20 of houses in any village will be enrolled to reduce any effects of diversion of mosquitoes by any treatment Epidemiological factors and baseline malaria prevalence will be recorded during a pre-intervention baseline month by questionnaire and rapid diagnostic test RDT using species-specific dip sticks for malaria Post intervention will be 5 further monthly visits during the malaria season to detect new cases by RDT reported fevers and operational data compliance adverse effects etc Primary outcome clinical measures will be incidence of malaria P falciparum P vivax comparing new cases in each of the 3 treatment non-treatment groups All cases will be treated promptly according to local policy At the end of the study all households which did not have a treated bed net will be provided with one
Secondary non-clinical outcome measures will include entomological data collected in houses using non using coils in sentinel villages at baseline during the study CDC mosquito light traps will be used to record number species feeding status parity age sporozoite infection rates of mosquitoes in houses using not-using coils following a randomised latin square design Such entomological data can be used to determine reduction in vector species mosquitoes entering houses using coils and or ITN
Ethical approval for the study has been granted by the LSHTM University of London Ethics Committee and the Yunnan Bureau of Health PRChina
The study will be a single-blind randomised clinical evaluation clustered at the household level There will be 4 treatment arms Coils Insecticide treated nets Coils ITN No treatment Each arm will include 400 households each with 5 people household total of 8000 people A maximum of 20 of houses in any village will be enrolled to reduce any effects of diversion of mosquitoes by any treatment Epidemiological factors and baseline malaria prevalence will be recorded during a pre-intervention baseline month by questionnaire and rapid diagnostic test RDT using species-specific dip sticks for malaria Post intervention will be 5 further monthly visits during the malaria season to detect new cases by RDT reported fevers and operational data compliance adverse effects etc Primary outcome clinical measures will be incidence of malaria P falciparum P vivax comparing new cases in each of the 3 treatment non-treatment groups All cases will be treated promptly according to local policy At the end of the study all households which did not have a treated bed net will be provided with one
Secondary non-clinical outcome measures will include entomological data collected in houses using non using coils in sentinel villages at baseline during the study CDC mosquito light traps will be used to record number species feeding status parity age sporozoite infection rates of mosquitoes in houses using not-using coils following a randomised latin square design Such entomological data can be used to determine reduction in vector species mosquitoes entering houses using coils and or ITN
Ethical approval for the study has been granted by the LSHTM University of London Ethics Committee and the Yunnan Bureau of Health PRChina
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LSHTM ITDCVP89 | None | None | None |